510(k) · Cleared
ClearedFamily of Iris Medical Endoprobe Handpieces
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Iridex Corp · GEX Powered Laser Surgical Instrument
Cleared on Oct 8, 2002 as substantially equivalent to K020374 (Iridex Corp, 2002) and 5 other predicates after a 90-day review. Its family tree reaches back 3 generations to 1989. 1 later device descends from it.
- Decided
- Oct 8, 2002
- Review
- 90 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 3 generations to K894841 (1989). 14 ancestors in all, the oldest K890086 (1989). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK894841 Iris Oculight (TM) SLIriderm Div. · 1989
- 2 generations backK960971 Oculight GLIriderm Div. · 1996
- 1 generation backK020374 Oculight SL/SLXIridex Corp · 2002
- This deviceK022228 Family of Iris Medical Endoprobe HandpiecesIridex Corp · 2002
- Descendant · cites it directly · 0 of its ownK133019 Fiberion Ophthalmic Endolaser ProbeEmtron Elektronik VE Mekanik Sanayi VE Ticaret Lim · 2015
Most influential descendants
Showing 1 of 1 · See all- K133019Fiberion Ophthalmic Endolaser ProbeEmtron Elektronik VE Mekanik Sanayi VE Ticaret Lim · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K894841 | Iris Oculight (TM) SL | Iriderm Div. | 1989 | — |
| −2 | K960971 | Oculight GL | Iriderm Div. | 1996 | — |
| −1 | K020374 | Oculight SL/SLX | Iridex Corp | 2002 | — |
| 0 (this device) | K022228 | Family of Iris Medical Endoprobe Handpieces | Iridex Corp | 2002 | — |
| +1 | K133019 | Fiberion Ophthalmic Endolaser Probe | Emtron Elektronik VE Mekanik Sanayi VE Ticaret Lim | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GEX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GEX device
- #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K020374 | Oculight SL/SLXSummary page 1…ially equivalent in intended use and/or method of operation to other currently legally marketed laser probes including IRIDEX Corporation’s IRIS Medical EndoProbe (K020374), the Alcon Endolaser Probes (K962592), the HGM Illuminating and Aspirating Probes (K93 1784 and K925663), the STI Aspirati… | 2002 |
| * | K962592 | Ophthalas 532 Solid State Photocoagulator, or Equivalent Laser SystemsSummary page 1…r method of operation to other currently legally marketed laser probes including IRIDEX Corporation’s IRIS Medical EndoProbe (K020374), the Alcon Endolaser Probes (K962592), the HGM Illuminating and Aspirating Probes (K93 1784 and K925663), the STI Aspirating Endo Ocular Probe with Illumination… | 1996 |
| * | K931784 | HGM Illuminating Imaging Endocular ProbeSummary page 1…laser probes including IRIDEX Corporation’s IRIS Medical EndoProbe (K020374), the Alcon Endolaser Probes (K962592), the HGM Illuminating and Aspirating Probes (K93 1784 and K925663), the STI Aspirating Endo Ocular Probe with Illumination (K921488), and the Infinitech Aspirating Laser Probe (K94… | 1994 |
| * | K925663 | HGM Aspirating Endoocular (TM) ProbeSummary page 1…bes including IRIDEX Corporation’s IRIS Medical EndoProbe (K020374), the Alcon Endolaser Probes (K962592), the HGM Illuminating and Aspirating Probes (K93 1784 and K925663), the STI Aspirating Endo Ocular Probe with Illumination (K921488), and the Infinitech Aspirating Laser Probe (K946135). Devi… | 1993 |
| * | K921488 | Aspirating Endo Ocular Probe W/IlluminationSummary page 1…the Alcon Endolaser Probes (K962592), the HGM Illuminating and Aspirating Probes (K93 1784 and K925663), the STI Aspirating Endo Ocular Probe with Illumination (K921488), and the Infinitech Aspirating Laser Probe (K946135). Device Description The family of IRIS Medical EndoProbe handpieces is… | 1992 |
| * | K946135 | Infinitech Aspirating Laser ProbeSummary page 1…minating and Aspirating Probes (K93 1784 and K925663), the STI Aspirating Endo Ocular Probe with Illumination (K921488), and the Infinitech Aspirating Laser Probe (K946135). Device Description The family of IRIS Medical EndoProbe handpieces is comprised of the following main components: a univ… | 1995 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133019 | Fiberion Ophthalmic Endolaser Probe | 2015 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 5.7 years on median.
- None of the 14 ancestors has a recall.
- Of its descendants, K133019 (Emtron Elektronik VE Mekanik Sanayi VE Ticaret Lim, 2015) has gone furthest, with 0 descendants of its own.
- 8 other devices also cite its predicate K020374.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
What is it indicated for?
The family of IRIS Medical EndoProbe handpieces is intended for use in performing ophthalmic laser treatments to deliver laser energy to the treatment area inside the eye, the aspiration function is indicated for use when unwanted fluid is present in the eye causing refraction or scattering of the laser beam from the intended treatment site, and the illumination function is indicated for use to illuminate the interior of the eye. The handpieces are…
Read the full statement (124 words)
The family of IRIS Medical EndoProbe handpieces is intended for use in performing ophthalmic laser treatments to deliver laser energy to the treatment area inside the eye, the aspiration function is indicated for use when unwanted fluid is present in the eye causing refraction or scattering of the laser beam from the intended treatment site, and the illumination function is indicated for use to illuminate the interior of the eye. The handpieces are offered in straight or angled styles, and with a universal SMA connector that allows the family of EndoProbe handpieces to be used with compatible laser systems, such as IRIS Medical and Lumenis. The handpieces are cleared for use for the particular indications of the laser system to which they are attached.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022228 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022228: Family of Iris Medical Endoprobe Handpieces.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022228
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026